Cancer Clinical Trial
Official title:
A Double-blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Efficacy of Orexigenic Therapy With Delta-9-tetrahydrocannabinol in Advanced Cancer Patients With Chemosensory Abnormalities - a Pilot Study
To investigate delta-9-tetrahydrocannabinol's (THC) ability to increase food intake and improve food enjoyment for advanced cancer patients with taste and/or smell (chemosensory) abnormalities.
Appetite stimulants are the common treatment for cancer-induced anorexia. However, only 30%
of advanced cancer patients respond and benefit from appetite stimulants, which may be due
in part to sensory abnormalities, as a person who is experiencing food aversion due to taste
and smell changes may be unable to respond to these agents. Of the appetite stimulants
available for use in clinical practice only Marinol, or THC, has the potential to increase
food intake by improving appetite as well as by amplifying the taste of food through the
brain's reward pathway.
A 22-day, double blind, randomized, placebo-controlled trial will be conducted. Participants
will start at 2.5mg of THC or placebo once daily for the first 3 days and then increase to
2.5mg of THC or placebo twice daily before lunch and supper. Participant's will complete the
following survey tools pre and post-treatment: Taste and Smell Survey to assess the severity
and change in chemosensory complaint scores; 3-day dietary record to determine the change in
caloric intake and shift in food preference by macronutrient analysis; 24-hour urine
collections to validate the 3-day dietary record; Satiety Labelled Intensity Magnitude scale
for subjective appetite ratings; Food Preference Checklist to assess objective shifts in
macronutrient and flavor preferences; Functional Assessment of Anorexia/Cachexia Therapy
questionnaire to assess participant's QOL; interview to determine the cause and effects of
chemosensory alterations; Edmonton Symptom Assessment Scale to assess nausea; and Side
Effect Survey to document the tolerability of the drug (post-treatment only). Participants
will complete the survey tools with the aid of the researcher. All tools are short and easy
to complete, which minimizes patient burden.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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